Device for two-way transfer of a liquid between a bottle and a cartridge

ABSTRACT

The invention concerns a device for the two-way transfer of a liquid ( 38 ) between a bottle ( 14 ) provided with a cap ( 44 ) capable of being perforated at a cartridge ( 12 ) comprising a cylindrical reservoir ( 26 ) wherein slides a piston ( 34 ) capable of being perforated. It comprises: a body ( 16 ) including means to be fixed on the bottle ( 14 ); a member ( 24 ) linking the piston ( 34 ) capable of being perforated to the body ( 16 ); a shuttle ( 20 ) relative to the body ( 16 ) and said linking member ( 24 ), the shuttle bearing a hollow needle ( 22 ) whereof one first end ( 112 ) is adapted to pierce the piston ( 34 ) and whereof the second end ( 114 ) is adapted to pierce the cap ( 44 ). The shuttle ( 20 ) is mobile between a piston wherein the needle ends ( 112, 114 ) are spaced apart from the piston ( 34 ) capable of being perforated and the cap ( 44 ) capable of being perforated and an end-of-stroke transferring position wherein the needle ends ( 112, 114 ) are received in the cartridge ( 12 ) and the bottle ( 14 ).

BACKGROUND OF THE INVENTION

The present invention relates to a device for two-way transfer of aliquid between a bottle, provided with a perforable stopper, and acartridge, comprising a cylindrical reservoir in which a perforablepiston slides.

Before proceeding with an injection using a syringe, it is common forthe practitioner to have to mix the liquid contained initially in thesyringe with a lyophilisate which is contained initially in a bottleprovided with a perforable stopper.

To mix these extemporaneously, the practitioner first injects all of theliquid contained in the syringe into the bottle. To this end, heperforates the stopper of the bottle with the aid of the needle which isprovided on the syringe and is intended for the injection proper.

After the lyophilisate has dissolved in the liquid, the mixture obtainedis reaspirated into the syringe through the injection needle. After theneedle has been removed from the bottle, the injection proper on thepatient is carried out.

Carrying out this extemporaneous mixing using such means is relativelyawkward, and it also poses the risk of the injection needle beingcontaminated upon its introduction into the bottle.

Devices are also known for transferring fluid between a bottle and aflexible bag intended in particular for transfusion. However, thesedevices are not designed to permit two-way transfer of a liquid betweena bottle and a syringe.

SUMMARY OF THE INVENTION

It is an object of the invention to make available a solution to theproblem of two-way transfer of a liquid between a bottle and aninjection syringe by making available a device which is easy to use andwhich guarantees satisfactory aseptic conditions.

To this end, the subject of the invention is a device for two-waytransfer of a liquid between a bottle, provided with a perforablestopper, and a cartridge, comprising a cylindrical reservoir in which aperforable piston slides, characterized in that it includes a bodyhaving means for fixing to the bottle, a member for connecting theperforable piston to the body, and a shuttle which is displaceablerelative to the body and to said connecting member, the shuttle bearinga hollow needle of which a first end is adapted to perforate the pistonand of which the second end is adapted to perforate the stopper, and inthat the shuttle is displaceable between an initial position, in whichthe needle ends are spaced apart from the perforable piston and theperforable stopper, and a final transfer position, in which the needleends are received in the cartridge and the bottle.

According to particular embodiments, the transfer device includes one ormore of the following characteristics:

said member for connecting the piston to the body comprises means forfixing to the body and is movable relative to the body from an initialposition, in which the fixing means are not in engagement with the body,and a final position, in which the fixing means are in engagement withthe body, thus ensuring that the piston is connected to the body;

said member for connecting the piston to the body comprises a threadedprotuberance for fixing it in a tapped recess in the piston;

said shuttle is mounted so as to slide in a conduit of said member forconnecting the piston to the body;

said conduit has on the inside an abutment limiting the displacementtravel of the shuttle;

it comprises a protective cap initially mounted on the body, whichprotective cap has means for fixing it to the reservoir of thecartridge;

the body has a continuation surrounding said shuttle and extendingbeyond the first end of the needle;

it comprises at least one abutment limiting the axial displacement ofthe reservoir relative to the connecting member, preventing removal ofthe piston from the reservoir; and

it comprises a cartridge support on which the reservoir of the cartridgebears axially, and in that one of the cartridge support and connectingmember has at least one projection, forming said abutment, received in alongitudinal slit of the other of the cartridge support and connectingmember, in order to limit their relative axial displacement between thereservoir and the connecting member.

The invention also relates to an injection kit including a device fortwo-way transfer as defined above, and a cartridge and a bottle, inwhich the cartridge is initially connected to the attachment member andthe bottle is initially connected to the body.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be better understood on reading the followingdescription which is given solely by way of example and in whichreference is made to the drawings, in which:

FIG. 1 is a longitudinal cross-sectional view of the transfer deviceaccording to the invention in its storage position;

FIGS. 2 and 3 are a longitudinal cross-sectional view and a perspectiveand partially cutaway view, respectively, of the transfer device in itsinitial phase of use;

FIG. 4 is a longitudinal cross-sectional view of the transfer deviceafter the needle ends have penetrated into the bottle and the cartridge;

FIG. 5 is a longitudinal cross-sectional view of the transfer deviceduring the phase of transfer of the fluid from the cartridge to thebottle;

FIG. 6 is a longitudinal cross-sectional view of the transfer deviceonce all the liquid has been transferred to the bottle;

FIG. 7 is a longitudinal cross-sectional view of the transfer devicewhen returning the mixture from the bottle to the cartridge;

FIG. 8 is a cross-sectional view of an alternative embodiment of thetransfer device according to the invention; and

FIG. 9 is a partial perspective view of the connecting member of thedevice in FIG. 8.

DETAILED DESCRIPTION OF THE INVENTION

The transfer device 10 shown in FIG. 1 is designed for two-way transferof fluid bet ween a cartridge 12 and a bottle 14. This device isgenerally of revolution about its longitudinal axis. It mainly comprisesa body 16, a protective cap 18, a shuttle 20 bearing a hollow needle 22,and a screw pusher or connecting member 24 intended to ensure axialsecuring of the movable piston of the cartridge 12 and the body 16.

In FIG. 1, the transfer device 10, equipped with the cartridge 12 andthe bottle 14, is shown in its storage position before use.

The cartridge 12 is intended for carrying out an injection after it hasbeen withdrawn from the transfer device and is equipped with aninjection needle and an actuating pusher. It comprises a cylindricalreservoir 26 which at the front has a narrowed neck 28 closed off by aperforable cap 30 supported by an a head 31. The cap 30 is designed tobe perforated by an injection needle mounted on the head 31 of thecartridge with a view to proceeding with an injection.

The rear end 32 of the reservoir 26, at the opposite end from the head31, is closed of by a perforable piston 34 mounted so as to slide in aleaktight manner inside the reservoir 26. The piston 34 has axially arecess 36 opening to the outside of the cartridge. This recess is tappedinternally in order subsequently to allow screwed insertion of anactuating pusher with a view to injecting the liquid contained in thecartridge.

The piston 34 is made of a polymer material of given Shore hardness.

The cartridge 12 is initially filled with an injectable liquid 38.

The bottle 14 comprises a glass body 40 with a neck 42 closed off by aperforable stopper 44. The neck 42 has a peripheral rim 46 defining ashoulder 48.

The perforable stopper 44 is made of a polymer material havingsubstantially the same Shore hardness as the material from which thepiston 34 is made. Thus, the piston 34 and the stopper 44 have the sameresistance to engagement of a sharp point. The materials from which thestopper 44 and the piston 34 are made are advantageously the same.Moreover, their thicknesses measured on the axis X—X are substantiallyidentical.

The bottle 14 is initially filled with a lyophilisate 50 constituting amedicinal substance in powder form. The oyophilisate 50 only partiallyfills the bottle. As is known per se, the bottle is sealed under vacuumso that the pressure inside the bottle is very much lower than theatmospheric pressure.

The body 16 has a conduit 60 passing axially through it from one end tothe other. At one end, called the lower end, the conduit 60 defines aseat 62 for receiving the bottle. This seat has a countersink 64 forreceiving the rim 46 of the bottle 14 in order to fix the latter. Inparticular, the countersink 64 is delimited by projections 66 definingprofiles for fixing the bottle. They are designed to cooperate with theshoulder 48 delimited by the neck of the bottle. The projections 66 haveramps converging from the open end of the seat 62 so as to make iteasier to introduce the bottle into the body.

At its other end, called the upper end, the conduit 60 has a cylindricalchamber 70 in which the shuttle 20 and the connecting member 24 arereceived. The chambers 62 and 70 are linked via an intermediate portion74 of smaller diameter.

The chamber 70 has a diameter which is sufficient to allow the passageof the reservoir 26. The total length of the chamber 70 and of theportion 74 is advantageously greater than that of the hollow needle 22.

The portion 74 is partially closed, at its end which opens into thechamber 62, by a membrane 75 which delimits an opening sufficient forthe passage of the needle 22. This membrane 75 partially covers themembrane 44 of the bottle 14.

At its upper end, the body 16 has on the outside a shoulder 76 reducingthe thickness of the body. This is designed for fitting the protectivecap 18.

The protective cap 18 generally has the form of a sleeve and defines aseat 78 which is able to receive the cartridge 16 and to be engaged fromits open end partially about the body 16.

It additionally comprises, on the outside, at its blind end, means 80for fixing on the head 31 of the cartridge. As is shown in perspectivein FIG. 3, the means 80 comprise a fork 82 delimited by two arms whichdefine a notch 84 which extends radially and whose width corresponds tothe diameter of the narrowed neck 28. Behind the fork 82, a chamber 86is provided in the protective cap 80 for the purpose of receiving thehead 31.

The connecting member 24 has a tubular shape. It comprises a cylindricalside wall 90 delimiting a conduit 91. It is closed off at an upper endby a threaded protuberance 92 projecting outward. This protuberance 92is screwed inside the tapped recess 36 and thus ensures that theconnecting member 24 and the piston 34 are axially secured.

The protuberance 92 is provided with an axial conduit 94 whose diametercorresponds substantially to the external diameter of the needle 22.

At its lower end, the connecting member 24 has, on the outer surface ofits wall 90, two successive grooves 96A, 96B which are spaced axiallyapart. They are separated by a distance I₁. The grooves 96A and 96B aredesigned to cooperate with a peripheral flange 98 formed in the conduit60 of the body. The flange is provided at the end of the intermediateportion 74 opening into the chamber 70.

The groove 96 and the peripheral flange 98 are designed to secure theconnecting member 24 and the body 16. The flange 98 is initially engagedin the lower groove 96A.

The distance I₁ is chosen to be smaller than the length of theintermediate portion 74, less the thickness of the membrane 75.

The wall 90 of the connecting member 24 has on the inside a peripheralflange 100 which delimits, in the space circumscribed by the wall 90, achamber 102 confining the shuttle 20. Thus, the flange 100 forms anaxial abutment for stopping the shuttle 20.

The shuttle 20 is made up of a cylindrical slide 110, with the hollowneedle 22 passing axially through the latter from one end to the other.Thus, a first end 112 of the needle protrudes beyond the slide 110 andis received initially in the passage 94. The second end 114 of theneedle 22 protrudes rearward of the slide 110 and is initially arrangedfacing the stopper 44 of the bottle.

The two ends of the needles have analogous bevels, so that they havesharp points with the same profiles facing the piston 34 and the stopper44.

The diameter of the slide 110 is greater than the diameter of thepassage defined by the membrane 75.

The cylindrical slide 110 has, along a part of its length received inthe confinement chamber 102, longitudinal ribs 116 (FIG. 3) which definea shoulder 118 which is designed to cooperate with the peripheral flange11 forming an abutment. The longitudinal ribs 116 guide the shuttle 20in translation inside the connecting member 24.

The length of the ribs 116 is smaller than the length of the confinementchamber 112 defined between the protuberance 92 and the flange 100. Thisdifference in length is labeled I₂.

Initially, as is shown in FIG. 1, the connecting member 24 is free fromthe body 16, so that the fixing means formed by the groove 96A and theflange 98 are in engagement. Likewise, the shuttle 20 initially bears onthe peripheral flange 100 by way of the shoulder 118, so that the end112 of the needle extends inside the protuberance 92. It is thus spacedapart from the perforable piston 34. The shuttle is then spaced apart bythe distance I₂ from the protuberance 92.

Likewise, the end 114 of the hollow needle is kept spaced apart from thestopper 44 by the lower end of the connecting member 24 bearing on theperipheral flange 98 and the shuttle 20 bearing on the flange 100. Thelower end of the slide 11 is then separated from the stopper 44 by adistance I₃.

The distances I₁, I₂ and I₃ are advantageously related to each othersuch that I₁=I₂+I₃.

The transfer devise 10 is used in the following way.

The protective cap 18 is first pulled off and turned. The fixing means80 are engaged about the head 31 of the cartridge, as is shown in FIGS.2 and 3.

The protective cap 18 and the body 16 are then moved together in thedirection of the arrow F4, as is shown in FIG. 4. Upon this axialdisplacement, the shuttle 20 moves relative to the body 16 until atransfer position is reached in which the end 112 protrudes inside thecartridge 12 after passing through the piston 34 and the end 114protrudes inside the bottle 14 after passing through the stopper 44.

The displacement of the protective cap 18 in fact brings about theengagement of the cartridge 12 in the chamber 70 of the body. Upon thisdisplacement, the connecting member 24 is displaced toward the bottle 14by being pushed by the cartridge. The groove 96A disengages from theperipheral flange 98 and the lower end of the member 24 is displaceduntil the flange 98 is received in the peripheral groove 96B. Theelastic engagement of the flange 98 in the groove 96B ensures definitiveaxial securing of the connecting member 24 and the body 16.

Upon displacement of the connecting member 24 along the course I₁, theshuttle 20, mounted so as to slide inside the connecting member 24 alonga course of length I₂, is also displaced relative to the body 16 and themember 24.

In fact, at the start of the sliding of the connecting member 24, theends 112 and 114 of the needle come to bear respectively on the piston34 and the stopper 44. These latter then perforate the piston 34 and thestopper 44 simultaneously as the cartridge 12 and the bottle 14 arebrought together. The ends of the needle then penetrate into thecartridge 12 and the bottle 14.

As the Shore hardness values for the piston 34 and for the stopper 44are identical, and likewise the two profiles of the ends 112 and 114 ofthe needle, the initial perforations of the piston and of the membraneare effected simultaneously, the needle being stressed only at these twoends.

At the end of displacement of the connecting member 24, the slide 110comes into abutment, on the one hand, on the end protuberance 92 of theconnecting member and, on the other hand, against the membrane 75extending over the stopper 44 which closes the bottle. In this position,shown in FIG. 4, the hollow needle 22 ensures communication between thebottle 14 and the cartridge 12.

As is illustrated in FIG. 5, when the reservoir 26 is subsequentlyengaged in the body 16 under the action of the protective cap 18displaced toward the body 16 in the direction of the arrow F5, theliquid 38 initially contained in the cartridge 12 is graduallytransferred into the bottle 14.

This transfer results from the engagement of the piston 34 inside thecylindrical reservoir 26, the piston 34 being held fixed in relation tothe body by way of the connecting member 24 which thus forms an abutmentwhile the reservoir 26 is displaced toward the body 16.

Filling the bottle 14 is made possible because it is initially at apressure below atmospheric pressure.

When, as is shown in FIG. 6, the piston 34 is bearing against the neck28 of the cartridge, most of the liquid initially contained in it istransferred into the bottle 14.

After sufficient shaking, the lyophilisate 50 dissolves in the liquid 38inside the bottle 14.

To transfer the extemporaneous mixture thus formed to the inside of thecartridge 12, the transfer device 10 is turned around, as is shown inFIG. 7, then the protective cap 18 is removed from the body 16 and theextemporaneous mixture is aspirated into the cartridge.

During the pull exerted on the cylindrical reservoir 26 of the cartridgein the direction of the arrow F7, the piston 34 is kept integral withthe body 16 by way of the connecting member 24 fixed to the body throughthe cooperation of the groove 96B and the peripheral flange 98.

The mixture is aspirated under the action of the movement of thecylindrical reservoir 26 relative to the piston 34. The relativemovement of the piston and of the reservoir in fact creates anunderpressure inside it, which leads to aspiration of the mixturecontained in the bottle 14.

After the cartridge 12 has been filled completely with theextemporaneous mixture, the cartridge 12 is detached from the connectingmember 24 by being unscrewed. It can then be used for injection purposesafter being fitted with an injection needle and an actuating pusher.

The transfer device thus without the cartridge is then discarded. Itshould be noted that in this position the end 112 of the needle isprotected on account of the continuation of the body 16, therebyavoiding any risk of accidental needle stick injuries. To this end, thelength of the body 16 is chosen to be sufficient to continue beyond theend 112 of the hollow needle.

The device according to the invention permits a transfer of the liquidbetween the cartridge and the bottle without any risk of contaminationof the liquid. This is because the two ends of the hollow needle are atall times protected inside the closed space delimited by the connectingmember 24, the body 16 and the bottle 14.

This protection is further reinforced by the presence of the protectivecap 18 during storage of the device.

Moreover, the simultaneous penetration of the two ends of the needlesavoids any risk of ambient air entering the cartridge or the bottle.

When the transfer device is pre-fitted with a bottle 14 and a cartridge12 before delivery, the transfer can be carried out without any need forthe cartridge or the bottle to come back into contact with the hand.This eliminates any risk of contamination from the hands.

An alternative embodiment of the transfer device according to theinvention is shown in FIGS. 8 and 9. In this figure, the elements whichare analogous or identical to those of the embodiment in FIGS. 1 through7 are designated by the same reference numbers.

This figure shows a transfer device 200 combined with a cartridge 12 anda bottle 14 containing a lyophilisate.

The transfer device 200 comprises a body 16 in which the bottle 14 isaxially immobilized, a connecting member 24 which slides relative to thebody, and a needle-holedr shuttle 20 which slides freely along the axisof the connecting member 24.

The transfer device 200 additionally comprises a cartridge support 202which has means 203 for axially fixing the cap 18.

In this embodiment, the connecting member 24 includes, in addition tothe cylindrical wall 90, a coaxial outer sleeve 204 which surrounds thecylindrical wall 90 and is connected to it by an annular wall 206. Thesleeve 204 is mounted so as to slide inside the body 16. It has raisedand recessed profiles 208 designed to cooperate with complementaryprofiles provided on the side wall of the body 16 in order to axiallysecure these after perforation of the stopper 44 by the end 114 of thehollow needle.

The sleeve 204 continues beyond the threaded protuberance 92 screwedinto the piston 34 of the cartridge.

As is shown in FIG. 9, the sleeve 204 has, in its side wall, two pairsof longitudinal slits 210, 212 offset by an angle of 90°. The slits 210have a length twice that of the slits 212. The lower end of the twopairs of slits 210, 212, arranged toward the bottle 14, extend at thesame level on the sleeve 204.

The cartridge support 202 comprises an inner tube 220 for receiving thebody 26 of the cartridge. It is partially closed at its lower end by ashoulder 222 on which the open end of the reservoir 26 of the cartridgebears axially. The shoulder 222 is continued by a tubular portion 224sliding along the cylindrical wall 90 of the connecting member. Inaddition, the tube 220 is surrounded in its lower part by a coaxialsleeve 230 bearing two diametrically opposite projections 232 which aredesigned to slide inside one or other of the pair of slits 210, 212.

Depending on the capacity of the cartridge 12 used with the transferdevice, the projections 232 are introduced into one or other of thepairs of slits. For a cartridge with a capacity of 1.3 mm, that is tosay a cartridge having a body of reduced length, the projections 232 arearranged in the short slits 212.

By contrast, when the transfer device is used with a cartridge having acapacity of 2.3 ml, that is to say a cartridge in which the length ofthe body is twice that of a cartridge of 1.3 ml, the projections 232 areengaged in the slits 210.

It will be appreciated that the cartridge support 202 guides thecartridge 12 axially as it slides relative to the connecting member 24.The presence of the two pairs of slits on the sleeve 204 of theconnecting member makes it possible to use the same transfer device withcartridges of two different capacities.

After the liquid contained initially in the cartridge has beentransferred to the inside of the bottle and it has been mixed with thelyophilisate, the mixture thus obtained is reaspirated into thecartridge 12 through the needle. For this purpose, the reservoir of thecartridge is pulled using the cap fixed to the needle support 202. Whenthe mixture is transferred to the cartridge 12, the projections 232slide along the slits 210 or 212. When the projections 232 come intocontact with the end of these slits, the latter form an abutment andoppose subsequent displacement of the cartridge 12. Thus, any risk ofthe piston 34 being withdrawn from the reservoir of the cartridge onaccount of too great a displacement of the latter is avoided by thepresence of the projections 232 forming an abutment. This is becausethese limit the course of displacement of the reservoir of the cartridgerelative to the connecting member 24 secured to the piston.

What is claimed is:
 1. A device for two-way transfer of a liquid (38)between a bottle (14), provided with a perforable stopper (44), and acartridge (12), comprising a cylindrical reservoir (26) in which aperforable piston (34) slides, characterized in that it includes: a body(16) having means for fixing to the bottle (14), a member (24) forconnecting the perforable piston (34) to the body (16), a shuttle (20)which is displaceable relative to the body (16) and to said connectingmember (24), the shuttle (20) bearing a hollow needle (22) of which afirst end (112) is adapted to perforate the piston (34) and of which thesecond end (114) is adapted to perforate the stopper (44), and in thatthe shuttle (20) is displaceable between an initial position, in whichthe needle ends (112, 14) are spaced apart from the perforable piston(34) and the perforable stopper (44), and a final transfer position, inwhich the needle ends (112, 114) are received in the cartridge (12) andthe bottle (14).
 2. The device as claimed in claim 1, characterized inthat said member (24) for connecting the piston to the body comprisesmeans (96) for fixing to the body (16) and is movable relative to thebody (16) from an initial position, in which the fixing means (96) arenot in engagement with the body (16), and a final position, in which thefixing means (96, 98) are in engagement with the body, thus ensuringthat the piston is connected to the body.
 3. The device as claimed inclaim 1, characterized in that said member (24) for connecting thepiston to the body comprises a threaded protuberance (92) for fixing itin a tapped recess (36) in the piston (34).
 4. The device as claimed inclaim 1, characterized in that said shuttle (20) is mounted so as toslide in a conduit (91) of said member (24) for connecting the piston tothe body.
 5. The device as claimed in claim 4, characterized in thatsaid conduit (91) has on the inside an abutment (100) limiting thedisplacement travel of the shuttle (20).
 6. The device as claimed inclaim 1, characterized in that it comprises a protective cap (18)initially mounted on the body (16), which protective cap (18) has means(80) for fixing it to the reservoir (26) of the cartridge.
 7. The deviceas claimed in claim 1, characterized in that the body (16) has acontinuation surrounding said shuttle (20) and extending beyond thefirst end (112) of the needle.
 8. The device as claimed in claim 1,characterized in that it comprises at least one abutment (232) limitingthe axial displacement of the reservoir (26) relative to the connectingmember (24), preventing removal of the piston (34) from the reservoir(26).
 9. The device as claimed in claim 8, characterized in that itcomprises a cartridge support (202) on which the reservoir (26) of thecartridge (12) bears axially, and in that one of the cartridge support(202) and connecting member (24) has at least one projection, formingsaid abutment (232), received in a longitudinal slit (210, 212) of theother of the cartridge support (202) and connecting member (24), inorder to limit their relative axial displacement between the reservoir(26) and the connecting member (24).
 10. An injection kit including adevice (10) for two-way transfer according to claim 1, and a cartridge(12) and a bottle (14), in which the cartridge (12) is initiallyconnected to the connecting member (24) and the bottle (14) is initiallyconnected to the body (16).